UNIVERSITY OF 
CANCER CENTER 
ROCHESTER 
MEDICAL ONCOLOGY DIVISION 
MEDICAL CENTER 
URCC 289 1M : The Treatment of Ovarian Cancer With Gene-Modified Cancer Cells: A 
Phase I Study 
CONSENT FORM 
PURPOSE OF THE STUDY 
This research study is intended for patients who have ovarian cancer, who have been 
treated for this cancer by surgery, chemotherapy, and possibly radiotherapy, and 
have been found to have disease remaining for which cure is virtually impossible by 
any current standard or conventional forms of treatment. This research study 
focuses on one possible new form of treatment. The investigational treatment in 
this study involves: 
1. The use of a proposed cancer treatment featuring a new--l aboratory-created— 
genetic structure. The proposed treatment consists of ovarian cancer cells 
taken from an unrelated patient in which we have placed a new gene that has 
been cut out of the Herpes Simplex Virus. The presence of this gene in the 
cancer cells should make it easy to kill these cells and perhaps kill your 
cancer cells, with an antiviral drug called Ganciclovir. The proposed gene- 
modified cancer cell agent is administered by injection into your abdominal 
cavity. This agent also contains a bacterial gene which will help us locate 
where the treated cells go in this part of your body. 
2. The drug, Ganciclovir, is given for 7 days following the gene-modified cells. 
Experimentally, it was found in animals that by injecting these cells into 
the abdominal cavity and killing the cells with Ganciclovir, both pre- 
existing cancer cells present in the abdomen and the gene-modified cells 
could be killed by this treatment procedure. 
The purpose of this study is to see if your ovarian cancer cells can be killed in 
this manner, to learn what dose is safe and has acceptable side effects, and to 
evaluate your body’s disease fighting response (called the immune response) to the 
gene-modified cells. 
DESCRIPTION OF PROCEDURES 
Prior to treatment and during treatment, blood tests and skin tests will be 
performed to evaluate your response to the treatment and to look for any harmful 
effects. Approximately 6 tablespoons of blood will be drawn on each occasion. Four 
different types of skin tests are given. These skin tests are antigens or proteins 
which your body’s defense system (immune system) can recognize as foreign. These 
tests will enable the physicians to monitor your immune system. 
1. Common antigens: Candida, streptokinase/streptodornase, and mumps are 
injected in the skin (given 4 times), 
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Rochester, New York 14642 
[602] 
Recombinant DNA Research, Volume 15 
